A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:October 12, 2015
End Date:December 28, 2018

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Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination With Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

The main purpose of this study is to evaluate the efficacy of an alternative dose of
ramucirumab in combination with paclitaxel in participants with second-line metastatic or
locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).


Inclusion Criteria:

- The participant has a diagnosis of gastric or GEJ adenocarcinoma.

- The participant has disease progression during or within 4 months after last dose of
first-line chemotherapy or during or within 6 months after the last dose of
neoadjuvant or adjuvant therapy.

- The participant received combination chemotherapy, which must include a platinum
and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.

- The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors
1.1.

- The participant has an Eastern Cooperative Oncology Group performance status of 0 or
1.

- The participant has adequate organ function:

- Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the
liver has tumor involvement, AST and ALT <5 × ULN.

- Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50
milliliters/minute.

- Urinary protein is <2+.

- Absolute neutrophil count ≥1.5 × 10^9/liter (L), platelets ≥100 × 10^9/L, and
hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).

- International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5
seconds above ULN.

- The participant has an estimated life expectancy of minimum 12 weeks.

- The participant has resolution to Grade 1 or less by Common Terminology Criteria for
Adverse Events Version 4.0, of all clinically significant toxic effects of previous
therapy.

- The participant, if male, is sterile or agrees to use a reliable method of birth
control.

- The participant, if female, is surgically sterile, is postmenopausal, or agrees to use
a highly effective method of birth control.

- The participant, if female and of child-bearing potential, must have a negative
pregnancy test.

Exclusion Criteria:

- The participant is receiving therapy with any of the following:

- Nonsteroidal anti-inflammatory agents.

- Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is
permitted.

- The participant received radiotherapy within 14 days prior to randomization.

- The participant received previous chemotherapy with a cumulative dose of >900 mg per
meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin.

- The participant has documented brain metastases or leptomeningeal disease.

- The participant has a significant bleeding disorder or vasculitis.

- The participant experienced any arterial thromboembolic event within 6 months.

- The participant has symptomatic congestive heart failure or symptomatic cardiac
arrhythmia.

- The participant has uncontrolled hypertension, despite antihypertensive intervention.

- The participant underwent major surgery within 28 days.

- The participant has a history of gastrointestinal perforation or fistula within 6
months.

- The participant has a history of inflammatory bowel disease or Crohn's disease
requiring medical intervention within 12 months.

- The participant has bowel obstruction or history of chronic diarrhea that is
considered clinically significant.

- The participant has either of the following:

- Child-pugh B or C cirrhosis.

- The participant has a serious illness or medical condition including:

- Human immunodeficiency virus infection.

- The participant has a concurrent active malignancy other than the following:

- Nonmelanomatous skin cancer.

- In situ carcinoma of the cervix or other noninvasive carcinoma or in situ
neoplasm.

- The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone
fracture.

- The participant experienced any Grade 3 or 4 venous thromboembolic event that is not
adequately treated.
We found this trial at
8
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Peter Enzinger
Phone: 617-632-5840
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brussels,
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Joseph Chao
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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New York, New York 10021
Principal Investigator: Manish Shah
Phone: 646-962-6200
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New York, NY
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Olympia, Washington 98502
Principal Investigator: Joseph Ye
Phone: 360-352-2900
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Olympia, WA
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Temple, Texas 76508
Principal Investigator: Lucas Wong
Phone: 254-724-5939
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Temple, TX
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Westwood, Kansas 66205
Principal Investigator: Raed Al-Rajabi
Phone: 913-588-6029
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Westwood, KS
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